Eu Ivdd
Eu Ivd General
On The Market
🇺🇸 United States
VALIDATE® SP3 Test Set
Devices (same UDI-DI)
1
Certificates
1
Countries
0
Notified Bodies
1
Basic Information
- Primary DI
- 00859110005920
- Basic UDI-DI Code
- B-00859110005920
- Reference
- 603ro
- Device Types
-
Single use
- Regulation
- Eu Ivdd
- Classification
- Eu Ivd General
- Status
- On The Market
- Manufacturer
- LGC Clinical Diagnostics, Inc.
Additional Description
VALIDATE SP3 Calibration Verification / Linearity Test Kit solutions are intended for in vitro diagnostic use in the quantitative determination of linearity, calibration verification and verification of reportable range for the following analytes: -1 acid glycoprotein (AAG), antistreptolysin O (ASO), -2 microglobulin (B2M), and immunoglobulin E (IGE).
CND Nomenclature Codes
| Code | Description |
|---|---|
| W0101050102 | UNASSAYED MULTICOMPONENT CONTROLS (CC) |
| W0101050101 | ASSAYED MULTICOMPONENT CONTROLS (CC) |
Certificates
| Type | Number | Notified Body | Status |
|---|---|---|---|
| IVDD Annex IV (excluding sections 4, 6) | 3822623 | DEKRA Certification B.V. | Expired |
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